Whole-food, plant-based diet for endometriosis pain and quality of life
A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
This trial will test whether switching to a whole-food, plant-based diet for 12 weeks helps women with endometriosis have less pain and better quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT07090096 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled 12-week trial will compare a whole-food, plant-based (WFPB) diet to participants' usual diets in women with endometriosis. Participants aged 18–45 with a surgical, imaging, or clinical diagnosis and a Modified Biberoglu and Behrman pelvic pain score of at least 5 will be randomly assigned to the intervention or control arm. The study will measure changes in pelvic pain and quality of life over the 12-week period, with participants asked to adhere to lifestyle considerations and attend study visits at UC San Diego. The intervention arm follows a WFPB diet while the control arm continues their usual diet.
Who should consider this trial
Good fit: Women aged 18–45 with a surgical, imaging, or clinical diagnosis of endometriosis, a Modified Biberoglu and Behrman pelvic pain score of at least 5, not already following a WFPB diet, and willing to be randomized and attend study visits at UCSD are ideal candidates.
Not a fit: Patients already following a whole-food, plant-based diet, those who are pregnant or breastfeeding, or those with recent substance use or unstable medical conditions may not receive benefit or be eligible.
Why it matters
Potential benefit: If effective, the diet could reduce pelvic pain and improve quality of life using a non-drug, non-surgical approach.
How similar studies have performed: Some observational and small interventional studies of anti-inflammatory and plant-forward diets suggest symptom improvement in endometriosis, but randomized controlled evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study visits, procedures, requirements, and availability for the duration of the study 3. Women with a surgical, imaging, or clinical diagnosis of endometriosis 4. Age 18-45 years 5. Stable health condition and medications for the past 3 months 6. Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9 7. Willing to be randomly assigned to either an active or a control group 8. Agreement to adhere to Lifestyle Considerations throughout the study duration Exclusion Criteria: 1. Smoking or drug abuse during the past six months 2. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 3. Already following a WFPB diet 4. Pregnant or breastfeeding, or plans of pregnancy within the study period 5. Hysterectomy or ovariectomy 6. Fibroids, ovarian cysts, pelvic inflammatory disease 7. Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease 8. Evidence of an eating disorder
Where this trial is running
La Jolla, California
- UCSD Health — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Sanjay K Agarwal, MD — UCSD
- Study coordinator: Chloe Delgado Ramirez
- Email: Krupp-wellness@ucsd.edu
- Phone: 619-929-0828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.